The Food and Drug Administration is increasing fees it charges for issuing copies of export certificates for medical devices (here). Since 2003, the agency has charged $175 for new export certificates, which state in writing that a given product meets certain specified requirements, and $15 for all subsequent export certificates issued for the same product. Effective Sept. 1, FDA is now increasing the fee for subsequent certificates to $85.
On Aug. 14 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 13 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 11 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
During the week of Aug. 3-9, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of:
On Aug. 6 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration issued its weekly Enforcement Report for Aug. 5 that lists the status of recalls and field corrections for food, drugs, biologics, and devices (here). The report covers both domestic and foreign firms.
On Aug. 5 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 4 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug 3 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: